FDA•MODERATE
Tosoh ST AIA-Pack Testosterone
Tosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
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FDA•MODERATEBD ChloraPrep Clear ApplicatorsCareFusion is recalling BD ChloraPrep Clear sterile solution applicators due to a potential lack of sterility from incomplete packaging seals.
FDA•MODERATEPhotera 400 Phototherapy DeviceDaavlin recalls Photera 400 phototherapy device due to incorrect UV sensor GAIN causing wrong output.
3 products
FDA•MODERATEMedline Total Knee PackMedline recalls Total Knee Pack kits with Zimmer Biomet bowls and spatulas over sterility risk.
2 products
FDA•MODERATEVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemVasoview Hemopro 2 Endoscopic Vessel Harvesting System is recalled due to an out-of-specification sterilization dose.
FDA•MODERATEMedtronic DLP One-Piece Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material risk.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic recalls Replacement Brush Heads model Papablic18B due to breakage risk.
2 products
FDA•MODERATECleviprex Injectable EmulsionChiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.
FDA•MODERATEBell Pharmaceuticals: Multiple Carbamide Peroxide ProductsBell Pharmaceuticals recalls store-brand carbamide peroxide ear drops for subpotency (low pH, ~0.6% assay).
11 products
FDA•MODERATEOrthofix MINIRAIL External Fixation DeviceOrthofix recalls MINIRAIL external fixation devices due to incorrect labeling.
8 products
FDA•MODERATEPillsbury Bread Rolls: Hard Roll Dough and Kaiser Roll DoughGeneral Mills is recalling Pillsbury Hard and Kaiser roll dough products due to potential glass contamination.
2 products
FDA•MODERATENystatin Cream USPPadagis is recalling 15 g tubes of Nystatin Cream USP due to subpotent drug results found during stability testing.
FDA•MODERATEOptima XR200/220/240amx Column Safety PawlGE HealthCare recalls Optima XR200/220/240amx systems over column safety pawl testing issue that could cause arm drop and patient injury.
3 products
FDA•MODERATENutricia North America: 2 productsNutricia recalls Liquid Hope and Nourish organic meal replacements due to subpotent vitamin A.
2 products
FDA•MODERATEBoston Scientific Rapid Refill Continuous Injection SystemBoston Scientific is recalling the Rapid Refill Continuous Injection System due to a risk of syringe disconnection during use.
FDA•MODERATEICU Medical Plum Duo Infusion PumpICU Medical recalls Plum Duo Infusion Pump v1.2.3 due to risk of delivering up to twice the programmed volume.
2 products
FDA•CRITICALTransvenous Pacing Electrode TrayArgon Medical recalls Transvenous Pacing Electrode Trays over non-sterile lidocaine ampules.
6 products
FDA•CRITICALAbiomed Impella RP Flex Introducer KitAbiomed recalls Impella RP Flex introducer kits over sheath leakage risk from manufacturing defects.
13 products
FDA•MODERATEOlympus Toomey Evacuator 30cc with AdaptorOlympus recalls Toomey Evacuator 30cc with Adaptor, Model 188, over sterilization concerns.
4 products
FDA•MODERATEVersius Surgeon ConsoleCMR Surgical is recalling the Versius Surgeon Console due to a cybersecurity risk involving the Secure Boot feature.
- Device RecallFDA•MODERATETMINI Miniature Robotic System Tracking Arrays
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays because a loose knob may cause surgical misalignment.
FDA•MODERATEOmniTract Surgical Retractor SystemIntegra LifeSciences is recalling the OmniTract Surgical Retractor System due to insufficient drying time instructions in the user manual.
FDA•MODERATEGSP Neonatal GALT KitThe GSP Neonatal GALT Kit is recalled due to reduced on-board stability, which may cause test failures and delays in patient results.
FDA•MODERATEFletcher CT/MR Shielded Applicator SetElekta recalls Fletcher CT/MR Shielded Applicator Set over risk of intrauterine tube tip detachment.
3 products
FDA•MODERATEPemetrexed for Injection 100mg/VialReliance Life Sciences recalls Pemetrexed for Injection 100mg/Vial over cGMP deviations.
4 products
FDA•MODERATEKlowen Custom Orthodontic SolutionKlowen is recalling the Custom Orthodontic Solution, model CIAS-800033, due to a defect that may cause incorrect bracket placement.
FDA•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH Enzymatic Hemoglobin A1c assay (Material No. 11097536) due to potential for inaccurate patient results.
FDA•MODERATEMedline Convenience KitsMedline recalls convenience kits with Medtronic temperature probes due to distribution error.
3 products
FDA•MODERATEGasco Industrial: Multiple Isopropyl Alcohol ProductsGasco recalls Isopropyl Alcohol 70% in 16 oz, 32 oz, and 1 gal sizes due to subpotency.
6 products
FDA•MODERATEFresenius 5008X Blood Tubing SetsFresenius is recalling 5008X blood tubing sets due to potential connection errors between the tubing and the 5008X CAREsystem.
FDA•MODERATEIntracept Access InstrumentsBoston Scientific is recalling Intracept Access Instruments due to a potential sterile barrier breach that could lead to severe infection.
FDA•MODERATEMasimo Radius VSM ECG Set and NIBP CuffMasimo recalls Radius VSM ECG Sets and NIBP Cuffs over false alarms and skin irritation risks.
2 products
FDA•LOWFexofenadine Hydrochloride Tablets 180 mgOhm Laboratories is recalling 180 mg Fexofenadine Hydrochloride tablets due to failed impurities and degradation specifications.
FDA•MODERATEMethohexital Sodium 100 mg/10 mLQuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL vials due to failed impurities and degradation specifications.
FDA•MODERATEMedline Remedy Specialized Silicone CreamMedline Remedy Specialized Silicone Cream is recalled due to an out-of-specification result for formaldehyde in the raw material.
FDA•MODERATEMethohexital Sodium for Injection 500 mgAvet Pharmaceuticals is recalling Methohexital Sodium for Injection 500 mg vials due to failed impurities and degradation specifications.
FDA•MODERATEAquacel Ag Surgical SP DressingConvaTec is recalling Aquacel Ag Surgical SP dressings because they were manufactured with a thickness exceeding specifications.
FDA•MODERATEOlympus Single Use Distal CoverOlympus is replacing the previous design of the MAJ-2315 Single Use Distal Cover used with the EVIS EXERA III Duodenovideoscope.
FDA•CRITICALFusia Asian Inspirations Kimchi & Tofu KimbapFusia Kimchi & Tofu Kimbap recalled due to undeclared fish allergen.
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets over N-nitroso impurity above safe limit.
3 products
FDA•MODERATEDextroamphetamine/Amphetamine Extended-Release CapsulesLannett is recalling 5 mg Dextroamphetamine/Amphetamine ER capsules due to a labeling mix-up where capsules contain immediate-release pellets.
FDA•MODERATEAsclemed: Multiple Lidocaine Hcl Injection ProductsAsclemed recalls Accucaine kits and Lidocaine HCl injection ampules over sterility concerns.
2 products
FDA•MODERATEA.T.S. 4000 TS Tourniquet Dual HoseZimmer Surgical recalls A.T.S. 4000 TS Tourniquet Dual Hoses over sterility breach risk.
2 products
FDA•MODERATEGore TAG Thoracic Branch Endoprosthesis Side Branch ComponentGore is recalling 30+ models of the TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation.
2 products
FDA•CRITICALReprocessed Electrophysiology and Ultrasound CathetersMedline is recalling reprocessed catheters due to residual particulate matter that may cause infection or embolism.
FDA•MODERATEBard Power-Trialysis Dialysis CatheterBard recalls dialysis catheters and drainage trays due to deficient lidocaine ampoules.
20 products
FDA•CRITICALMedtronic Harmony Delivery Catheter SystemMedtronic is recalling the Harmony Delivery Catheter System due to a manufacturing defect that may cause the distal tip to detach during use.
FDA•MODERATESolar GI System Water PerfusionLaborie is recalling Solar GI System configurations due to moisture accumulation that may affect pressure measurement performance.
FDA•MODERATECovidien Shiley Disposable Decannulation PlugCovidien is recalling 12+ models of Shiley Disposable Decannulation Plugs due to incorrect labeling regarding DEHP content.
2 products
FDA•MODERATEGlucagon Emergency KitLupin recalls Glucagon Emergency Kits due to a stability test failure that may impair emergency use.
3 products